Recombinant human erythropoietin preparation without human albumin

Abstract

The invention discloses a recombinant human erythropoietin preparation without human albumin. The recombinant human erythropoietin preparation without human albumin is characterized by comprising the following components: dosages of human erythropoietin, 0.1% to 2% (W / V) of amino acid and salt derivatives thereof, 0.001% to 0.01% (V / V) of non-ionic surface active agent, a physiological soluble buffer solution which can control the pH of the preparation to be 5.0 to 8.0, an iso-osmotic agent consisting of 1% to 5% (W / V) of mannitol or 0.1% to 0.9% (W / V) of sodium chloride, and the balance of water. With the adoption of the preparation, the risks of potential virus threats and protein allergy caused by human albumin in use can be avoided, the content accuracy of recombinant human erythropoietin injection can be ensured, and the stability of high-temperature storage is improved.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a recombinant human erythropoietin preparation without human serum albumin. Background technique [0002] Recombinant human erythropoietin (EPO) is a glycoprotein whose main physiological function is to stimulate the formation of hemoglobin or red blood cells in the bone marrow. It is mainly produced by the kidney and enters the bone marrow through circulating blood to play a role. Recombinant human erythropoietin has the same structure and physiological function as natural erythropoietin, and clinical recombinant human erythropoietin injection is widely used in renal anemia, red blood cell mobilization in the perioperative period of surgery, tumor chemotherapy and anemia caused by various reasons etc., is a good blood substitute. [0003] The working concentration of EPO in the body is very low, and the human body is very sensitive to small changes in EPO levels, so the treatm...

AI Technical Summary

Problems solved by technology

However, in recent years, evidence has shown that HES is harmful to kidney toxicity. The Journal of the American Medical Association [JAMA2013, 309(7): 678] disclosed the risk of acute renal failure and death in patients with severe HES. Therefore, hydroxyethyl starch is currently There are great risks and disputes in the process of use. In order to improve the safety and reliability of the preparation, it should be avoided as much as possible when it is not necessary.

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